Multimodal Telerehabilitation in Patients Undergoing CAR-T Cell Immunotherapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Utah

About this trial

The proposed multimodal telerehabilitation model allows a rehabilitation therapy team to set up individualized rehabilitation plans using a web-based care management portal and monitor patient progress online. Patients at home follow a safe and effective personalized exercise and nutrition plan guided by interactive touch-screen technology combined with behavioral counseling, social support, and interactive education and empowerment. The design of the telerehabilitation system is based on the cloud-based Internet-of-Things architecture allowing real-time monitoring of cardiovascular parameters and exercise performance. The patient's level of exertion during exercise is automatically identified by a validated AI-driven algorithm supporting exercise safety and efficacy. The ultimate goal of this pilot feasibility project is to establish the extent of the impact of the proposed patient-centered cancer telerehabilitation model on disease-specific quality of life, and functional and symptom outcomes and to obtain sufficient evidence for a definitive randomized clinical trial evaluating this approach in a multi-center study.

Eligibility criteria

Qualifiers

age >21

confirmed diagnosis of lymphoma or myeloma

commercial FDA-approved CAR-T delivery planned for ≥4 weeks following enrollment

Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Disqualifiers

have unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers, painful or unstable bony metastases, or recent skeletal fractures;

are engaged in a regular exercise rehabilitation program;

have relocation plans within next 6 months;

participate in another clinical trial.

Trial design

Treatments tested in this trial

  • Home Automated Telemanagement (HAT) Patient Unit

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Utah

Lead sponsor

United States Department of Defense

Collaborator